Cases
463
Deaths
150
Average CFR (%)
32%
Cases distribution in 🇨🇩 North Kivu
| Characteristic | Death N = 1501 |
Full recovery with sequelae N = 11 |
Full recovery without sequelae N = 2571 |
Referred to another facility N = 31 |
Unknown N = 521 |
p-value2 |
|---|---|---|---|---|---|---|
| Age at admission | – | – | – | – | – | 0.83 |
| Median (Min, Max) | 30 (3, 70) | 42 (42, 42) | 32 (1, 71) | 37 (25, 48) | 29 (1, 63) | – |
| Age Group | – | – | – | – | – | – |
| <5 | 2 (1.4%) | 0 (0%) | 7 (2.9%) | 0 (0%) | 2 (4.1%) | – |
| 5-17 | 18 (12%) | 0 (0%) | 20 (8.2%) | 0 (0%) | 6 (12%) | – |
| 18-24 | 26 (18%) | 0 (0%) | 53 (22%) | 0 (0%) | 11 (22%) | – |
| 25-34 | 44 (30%) | 0 (0%) | 60 (25%) | 1 (50%) | 10 (20%) | – |
| 35-49 | 37 (25%) | 1 (100%) | 70 (29%) | 1 (50%) | 13 (27%) | – |
| 50+ | 19 (13%) | 0 (0%) | 33 (14%) | 0 (0%) | 7 (14%) | – |
| Gender | – | – | – | – | – | 0.88 |
| Male | 67 (45%) | 0 (0%) | 110 (43%) | 2 (67%) | 24 (46%) | – |
| Female | 83 (55%) | 1 (100%) | 147 (57%) | 1 (33%) | 28 (54%) | – |
| Patient occupation | – | – | – | – | – | 0.02 |
| Healthcare worker | 9 (11%) | 0 (0%) | 33 (23%) | 0 (0%) | 3 (6.8%) | – |
| Non-healthcare worker | 38 (46%) | 1 (100%) | 66 (46%) | 1 (50%) | 29 (66%) | – |
| Unknown | 36 (43%) | 0 (0%) | 43 (30%) | 1 (50%) | 12 (27%) | – |
| Is the patient pregnant? | – | – | – | – | – | – |
| Yes | 5 (100%) | 0 (NA%) | 11 (100%) | 0 (NA%) | 0 (NA%) | – |
| Does the patient have any comorbid conditions? | – | – | – | – | – | – |
| Yes | 4 (100%) | 0 (NA%) | 3 (100%) | 0 (NA%) | 1 (100%) | – |
| Diabetes | – | – | – | – | – | – |
| Yes | 1 (100%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | – |
| HIV | 2 (67%) | 0 (NA%) | 1 (100%) | 0 (NA%) | 0 (NA%) | 1.00 |
| Chronic pulmonary disease | – | – | – | – | – | – |
| Yes | 0 (NA%) | 0 (NA%) | 1 (100%) | 0 (NA%) | 0 (NA%) | – |
| Bleeding | – | – | – | – | – | – |
| Yes | 1 (100%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | 1 (100%) | – |
| Fever | – | – | – | – | – | – |
| Yes | 88 (100%) | 0 (NA%) | 144 (100%) | 2 (100%) | 26 (100%) | – |
| Diarrhoea | – | – | – | – | – | – |
| Yes | 70 (100%) | 1 (100%) | 77 (100%) | 0 (NA%) | 15 (100%) | – |
| Shock | – | – | – | – | – | – |
| Yes | 2 (100%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | – |
| Confusion | – | – | – | – | – | – |
| Yes | 1 (100%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | – |
| Ebola RDT | – | – | – | – | – | 0.76 |
| Oraquick | 2 (1.6%) | 0 (NA%) | 2 (0.9%) | 0 (0%) | 0 (0%) | – |
| Not done | 126 (98%) | 0 (NA%) | 212 (99%) | 2 (100%) | 35 (100%) | – |
| Ct (lowest) | – | – | – | – | – | 0.00 |
| Median (Min, Max) | 20 (0, 38) | -- | 25 (0, 40) | 22 (16, 34) | 24 (0, 33) | – |
| Result of GeneXpert PCR | – | – | – | – | – | 0.80 |
| Positive | 130 (100%) | 0 (NA%) | 212 (99%) | 3 (100%) | 41 (100%) | – |
| Negative | 0 (0%) | 0 (NA%) | 2 (0.9%) | 0 (0%) | 0 (0%) | – |
| Indeterminate | 0 (0%) | 0 (NA%) | 1 (0.5%) | 0 (0%) | 0 (0%) | – |
| Platelets (x10⁹/L) | – | – | – | – | – | 0.67 |
| Median (Min, Max) | 164 (30, 385) | -- | 142 (27, 385) | 199 (181, 216) | 168 (168, 168) | – |
| Haemoglobin (g/L) | – | – | – | – | – | 0.54 |
| Median (Min, Max) | 13.80 (10.60, 17.90) | -- | 12.90 (9.00, 17.90) | 12.05 (10.10, 14.00) | 11.20 (11.20, 11.20) | – |
| Calcium (mmol/L) US | – | – | – | – | – | 0.00 |
| Median (Min, Max) | 7.75 (4.00, 9.00) | 4.00 (4.00, 4.00) | 8.70 (4.00, 10.40) | 9.45 (9.00, 9.90) | 8.05 (7.80, 8.90) | – |
| Antibacterial treatment | – | – | – | – | – | – |
| Yes | 136 (100%) | 1 (100%) | 206 (100%) | 1 (100%) | 46 (100%) | – |
| Antimalarial treatment | – | – | – | – | – | – |
| Yes | 119 (100%) | 1 (100%) | 176 (100%) | 0 (NA%) | 41 (100%) | – |
| Ebola experimental treatment | – | – | – | – | – | – |
| Yes | 72 (100%) | 0 (NA%) | 105 (100%) | 2 (100%) | 23 (100%) | – |
| Oral/orogastric fluids | – | – | – | – | – | – |
| Yes | 21 (100%) | 1 (100%) | 48 (100%) | 1 (100%) | 8 (100%) | – |
| Oxygen therapy | – | – | – | – | – | – |
| Yes | 3 (100%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | – |
| Blood transfusion | – | – | – | – | – | – |
| Yes | 4 (100%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | – |
| Vasopressors/inotropes | – | – | – | – | – | – |
| Yes | 1 (100%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | 0 (NA%) | – |
| 1 n (%) | ||||||
| 2 Kruskal-Wallis rank sum test; NA; Fisher’s exact test | ||||||
| Characteristic | Male N = 2031 |
Female N = 2601 |
p-value2 |
|---|---|---|---|
| Age at admission | – | – | 0.45 |
| Median (Min, Max) | 32 (1, 71) | 30 (1, 70) | – |
| Age Group | – | – | – |
| <5 | 5 (2.6%) | 6 (2.4%) | – |
| 5-17 | 19 (10%) | 25 (10.0%) | – |
| 18-24 | 30 (16%) | 60 (24%) | – |
| 25-34 | 55 (29%) | 60 (24%) | – |
| 35-49 | 62 (33%) | 60 (24%) | – |
| 50+ | 19 (10%) | 40 (16%) | – |
| Patient occupation | – | – | 0.17 |
| Healthcare worker | 22 (18%) | 23 (15%) | – |
| Non-healthcare worker | 64 (54%) | 71 (46%) | – |
| Unknown | 33 (28%) | 59 (39%) | – |
| Is the patient pregnant? | – | – | – |
| Yes | 0 (NA%) | 16 (100%) | – |
| Does the patient have any comorbid conditions? | – | – | – |
| Yes | 3 (100%) | 5 (100%) | – |
| Diabetes | – | – | – |
| Yes | 0 (NA%) | 1 (100%) | – |
| HIV | 1 (100%) | 2 (67%) | 1.00 |
| Chronic pulmonary disease | – | – | – |
| Yes | 1 (100%) | 0 (NA%) | – |
| Bleeding | – | – | – |
| Yes | 1 (100%) | 1 (100%) | – |
| Fever | – | – | – |
| Yes | 115 (100%) | 145 (100%) | – |
| Diarrhoea | – | – | – |
| Yes | 62 (100%) | 101 (100%) | – |
| Shock | – | – | – |
| Yes | 1 (100%) | 1 (100%) | – |
| Confusion | – | – | – |
| Yes | 0 (NA%) | 1 (100%) | – |
| Ebola RDT | – | – | 0.63 |
| Oraquick | 1 (0.6%) | 3 (1.4%) | – |
| Not done | 170 (99%) | 205 (99%) | – |
| Ct (lowest) | – | – | 0.37 |
| Median (Min, Max) | 22 (0, 38) | 23 (0, 40) | – |
| Result of GeneXpert PCR | – | – | 0.34 |
| Positive | 173 (99%) | 213 (99%) | – |
| Negative | 0 (0%) | 2 (0.9%) | – |
| Indeterminate | 1 (0.6%) | 0 (0%) | – |
| Platelets (x10⁹/L) | – | – | 0.84 |
| Median (Min, Max) | 166 (142, 181) | 153 (27, 385) | – |
| Haemoglobin (g/L) | – | – | 0.74 |
| Median (Min, Max) | 12.45 (10.60, 14.00) | 13.15 (9.00, 17.90) | – |
| Calcium (mmol/L) US | – | – | 0.90 |
| Median (Min, Max) | 8.30 (4.00, 9.70) | 8.25 (4.00, 10.40) | – |
| Antibacterial treatment | – | – | – |
| Yes | 173 (100%) | 217 (100%) | – |
| Antimalarial treatment | – | – | – |
| Yes | 160 (100%) | 177 (100%) | – |
| Ebola experimental treatment | – | – | – |
| Yes | 89 (100%) | 113 (100%) | – |
| Oral/orogastric fluids | – | – | – |
| Yes | 38 (100%) | 41 (100%) | – |
| Oxygen therapy | – | – | – |
| Yes | 1 (100%) | 2 (100%) | – |
| Blood transfusion | – | – | – |
| Yes | 2 (100%) | 2 (100%) | – |
| Vasopressors/inotropes | – | – | – |
| Yes | 1 (100%) | 0 (NA%) | – |
| Outcome at discharge | – | – | 0.88 |
| Death | 67 (33%) | 83 (32%) | – |
| Full recovery with sequelae | 0 (0%) | 1 (0.4%) | – |
| Full recovery without sequelae | 110 (54%) | 147 (57%) | – |
| Referred to another facility | 2 (1.0%) | 1 (0.4%) | – |
| Unknown | 24 (12%) | 28 (11%) | – |
| 1 n (%) | |||
| 2 Wilcoxon rank sum test; NA; Pearson’s Chi-squared test; Fisher’s exact test | |||
| Symptoms Prevalence at Admission | |||
|---|---|---|---|
| Variable | Number of Cases | Prevalence | Frequency1 |
| Fatigue | 69.1% | 320 / 463 | |
| Anorexia | 57.5% | 266 / 463 | |
| Fever | 56.2% | 260 / 463 | |
| Headache | 49.5% | 229 / 463 | |
| Nausea | 46.4% | 215 / 463 | |
| Weakness | 41.7% | 193 / 463 | |
| Vomiting | 38.7% | 179 / 463 | |
| Body Pain | 36.1% | 167 / 463 | |
| Diarrhoea | 35.2% | 163 / 463 | |
| Abdominal pain | 34.3% | 159 / 463 | |
| Myalgia | 33.9% | 157 / 463 | |
| Chest Pain | 17.9% | 83 / 463 | |
| Difficulty swallowing | 13.6% | 63 / 463 | |
| Sore Throat | 10.4% | 48 / 463 | |
| Difficulty breathing | 5.8% | 27 / 463 | |
| Hiccups | 5.8% | 27 / 463 | |
| Malaise | 5.4% | 25 / 463 | |
| Irriability/Confusion | 1.3% | 6 / 463 | |
| 1 Among all cases, assuming missing = Absence. | |||
| Characteristic | Death N = 1501 |
Recovered N = 2581 |
p-value2 |
|---|---|---|---|
| Fever | 88 (59%) | 144 (56%) | 0.57 |
| Fatigue | 115 (77%) | 168 (65%) | 0.01 |
| Weakness | 76 (51%) | 91 (35%) | 0.00 |
| Malaise | 6 (4.0%) | 15 (5.8%) | 0.42 |
| Myalgia | 62 (41%) | 77 (30%) | 0.02 |
| Anorexia | 94 (63%) | 147 (57%) | 0.26 |
| Sore Throat | 26 (17%) | 20 (7.8%) | 0.00 |
| Headache | 78 (52%) | 124 (48%) | 0.44 |
| Chest Pain | 32 (21%) | 47 (18%) | 0.44 |
| Body Pain | 62 (41%) | 85 (33%) | 0.09 |
| Hiccups | 10 (6.7%) | 17 (6.6%) | 0.98 |
| Difficulty breathing | 14 (9.3%) | 11 (4.3%) | 0.04 |
| Difficulty swallowing | 33 (22%) | 27 (10%) | 0.00 |
| Abdominal pain | 61 (41%) | 84 (33%) | 0.10 |
| Diarrhoea | 70 (47%) | 78 (30%) | 0.00 |
| Nausea | 88 (59%) | 112 (43%) | 0.00 |
| Vomiting | 67 (45%) | 98 (38%) | 0.18 |
| Irriability/Confusion | 3 (2.0%) | 2 (0.8%) | 0.36 |
| 1 n (%) | |||
| 2 Pearson’s Chi-squared test; Fisher’s exact test | |||
| Characteristic | Death N = 1501 |
Recovered N = 2581 |
p-value2 |
|---|---|---|---|
| Antibacterial treatment | 136 (91%) | 207 (80%) | 0.01 |
| Antimalarial treatment | 119 (79%) | 177 (69%) | 0.02 |
| Other type of treatment | 134 (89%) | 202 (78%) | 0.00 |
| Ebola experimental treatment | 72 (48%) | 105 (41%) | 0.15 |
| Oral/orogastric fluids | 21 (14%) | 49 (19%) | 0.20 |
| Oxygen therapy | 3 (2.0%) | 0 (0%) | 0.05 |
| Blood transfusion | 4 (2.7%) | 0 (0%) | 0.02 |
| Vasopressors/inotropes | 1 (0.7%) | 0 (0%) | 0.37 |
| Remdesivir (GS-5734) | 26 (17%) | 22 (8.5%) | 0.01 |
| Zmapp | 5 (3.3%) | 1 (0.4%) | 0.03 |
| mAb114 | 18 (12%) | 53 (21%) | 0.03 |
| REGN3470-3471-3479 | 22 (15%) | 27 (10%) | 0.21 |
| 1 n (%) | |||
| 2 Pearson’s Chi-squared test; Fisher’s exact test | |||
| Characteristic | Death N = 150 |
Recovered N = 258 |
p-value1 |
|---|---|---|---|
| Haemoglobin (g/L) | – | – | 0.28 |
| Median (Min, Max) | 13.80 (10.60, 17.90) | 12.90 (9.00, 17.90) | – |
| WBC count (x10⁹/L) | – | – | 0.33 |
| Median (Min, Max) | 10 (3, 81) | 8 (2, 52) | – |
| Platelets (x10⁹/L) | – | – | 0.56 |
| Median (Min, Max) | 164 (30, 385) | 142 (27, 385) | – |
| ALT/SGPT (U/L) US | – | – | 0.00 |
| Median (Min, Max) | 397 (22, 2,000) | 136 (12, 1,100) | – |
| AST/SGO (U/L) US | – | – | 0.02 |
| Median (Min, Max) | 726 (40, 2,000) | 136 (11, 2,000) | – |
| Bilirubin (µmol/L) US | – | – | 0.00 |
| Median (Min, Max) | 0.75 (0.40, 10.00) | 0.50 (0.10, 2.30) | – |
| Creatinine ( µmol/L) US | – | – | 0.02 |
| Median (Min, Max) | 1.90 (0.50, 11.10) | 1.05 (0.20, 12.00) | – |
| Potassium (mmol/L) US | – | – | 0.03 |
| Median (Min, Max) | 4.30 (2.70, 58.00) | 3.80 (1.50, 6.80) | – |
| Urea (mmol/L) US | – | – | 0.01 |
| Median (Min, Max) | 27 (5, 151) | 10 (3, 142) | – |
| Creatinine kinase (U/L) US | – | – | 0.00 |
| Median (Min, Max) | 1,056 (79, 5,000) | 335 (8, 5,000) | – |
| Calcium (mmol/L) US | – | – | 0.00 |
| Median (Min, Max) | 7.75 (4.00, 9.00) | 8.70 (4.00, 10.40) | – |
| Sodium (mmol/L) US | – | – | 0.68 |
| Median (Min, Max) | 132 (123, 180) | 132 (123, 152) | – |
| Glucose (mmol/L) US | – | – | 0.86 |
| Median (Min, Max) | 93 (50, 406) | 93 (42, 308) | – |
| 1 Wilcoxon rank sum test | |||
| Characteristic | Death N = 1501 |
Recovered N = 2581 |
p-value2 |
|---|---|---|---|
| Bleeding | 1 (0.7%) | 0 (0%) | 0.37 |
| Shock | 2 (1.3%) | 0 (0%) | 0.13 |
| Confusion | 1 (0.7%) | 0 (0%) | 0.37 |
| Coma (P/U in AVPU scoring) | 2 (1.3%) | 0 (0%) | 0.13 |
| 1 n (%) | |||
| 2 Fisher’s exact test | |||
Experimental Treatments (admission)
Intravenous Fluid
Final Outcome
| Characteristic | Mornings N = 1,1851 |
Middays N = 1,1851 |
Evenings N = 1,1851 |
p-value2 |
|---|---|---|---|---|
| Seizure | 4 (0.3%) | 5 (0.4%) | 2 (0.2%) | 0.65 |
| Signs of shock | 4 (0.3%) | 5 (0.4%) | 5 (0.4%) | 1.00 |
| Agitation | 10 (0.8%) | 8 (0.7%) | 8 (0.7%) | 0.86 |
| Anuria | 10 (0.8%) | 12 (1.0%) | 10 (0.8%) | 0.88 |
| Difficulty breathing | 17 (1.4%) | 8 (0.7%) | 14 (1.2%) | 0.20 |
| Desorientation | 23 (1.9%) | 15 (1.3%) | 11 (0.9%) | 0.10 |
| Dysphagia | 27 (2.3%) | 21 (1.8%) | 23 (1.9%) | 0.67 |
| Signs of dehydration | 57 (4.8%) | 40 (3.4%) | 42 (3.5%) | 0.14 |
| Headache | 76 (6.4%) | 48 (4.1%) | 52 (4.4%) | 0.02 |
| Nausea | 79 (6.7%) | 49 (4.1%) | 53 (4.5%) | 0.01 |
| Myalgia | 79 (6.7%) | 41 (3.5%) | 49 (4.1%) | 0.00 |
| Unusual bleeding/bruising | 102 (8.6%) | 67 (5.7%) | 78 (6.6%) | 0.02 |
| Vomiting | 117 (9.9%) | 70 (5.9%) | 91 (7.7%) | 0.00 |
| Weakness | 157 (13%) | 121 (10%) | 117 (9.9%) | 0.02 |
| Anorexia | 143 (12%) | 97 (8.2%) | 108 (9.1%) | 0.00 |
| Diarrhoea | 259 (22%) | 192 (16%) | 220 (19%) | 0.00 |
| Fatigue | 283 (24%) | 208 (18%) | 237 (20%) | 0.00 |
| 1 n (%) | ||||
| 2 Fisher’s exact test; Pearson’s Chi-squared test | ||||
| Symptom | Pre-infusion N = 2641 |
Post-infusion N = 2601 |
p-value2 |
|---|---|---|---|
| Dizziness | >0.9 | ||
| Mild | 5 (1.9%) | 4 (1.6%) | |
| Not present | 253 (98%) | 249 (98%) | |
| Dyspepsia | 0.6 | ||
| Mild | 3 (1.2%) | 4 (1.6%) | |
| Moderate | 5 (1.9%) | 2 (0.8%) | |
| Not present | 250 (97%) | 245 (98%) | |
| Tremor | 0.2 | ||
| Mild | 6 (2.3%) | 2 (0.8%) | |
| Moderate | 0 (0%) | 1 (0.4%) | |
| Not present | 252 (98%) | 248 (98%) | |
| Severe | 0 (0%) | 1 (0.4%) | |
| Pruritis | 0.8 | ||
| Mild | 3 (1.2%) | 2 (0.8%) | |
| Not present | 251 (99%) | 233 (99%) | |
| Severe | 0 (0%) | 1 (0.4%) | |
| Eruption | >0.9 | ||
| Mild | 3 (1.2%) | 2 (0.8%) | |
| Moderate | 1 (0.4%) | 0 (0%) | |
| Not present | 250 (98%) | 234 (99%) | |
| Bleeding | >0.9 | ||
| Mild | 12 (4.7%) | 12 (5.1%) | |
| Moderate | 3 (1.2%) | 3 (1.3%) | |
| Not present | 237 (94%) | 218 (93%) | |
| Severe | 1 (0.4%) | 1 (0.4%) | |
| Anorexia | 0.8 | ||
| Life-threatening | 0 (0%) | 1 (0.4%) | |
| Mild | 24 (9.6%) | 21 (9.1%) | |
| Moderate | 5 (2.0%) | 3 (1.3%) | |
| Not present | 220 (88%) | 207 (89%) | |
| Diarrhoea | 0.8 | ||
| Life-threatening | 0 (0%) | 1 (0.4%) | |
| Mild | 26 (10%) | 21 (9.1%) | |
| Moderate | 14 (5.6%) | 10 (4.3%) | |
| Not present | 208 (83%) | 196 (85%) | |
| Severe | 4 (1.6%) | 2 (0.9%) | |
| Nausea | 0.9 | ||
| Mild | 34 (13%) | 30 (13%) | |
| Moderate | 5 (2.0%) | 3 (1.3%) | |
| Not present | 211 (84%) | 202 (86%) | |
| Severe | 2 (0.8%) | 1 (0.4%) | |
| Vomiting | 0.2 | ||
| Mild | 24 (9.6%) | 20 (8.5%) | |
| Moderate | 9 (3.6%) | 2 (0.9%) | |
| Not present | 213 (86%) | 211 (90%) | |
| Severe | 3 (1.2%) | 2 (0.9%) | |
| Constipation | |||
| Not present | 246 (100%) | 231 (100%) | |
| Headache | 0.057 | ||
| Mild | 12 (4.9%) | 4 (1.7%) | |
| Moderate | 0 (0%) | 1 (0.4%) | |
| Not present | 232 (95%) | 225 (98%) | |
| Hypertension | 0.7 | ||
| Mild | 3 (1.2%) | 4 (1.7%) | |
| Moderate | 1 (0.4%) | 2 (0.9%) | |
| Not present | 240 (98%) | 224 (97%) | |
| Hypotension | 0.3 | ||
| Mild | 16 (6.5%) | 11 (4.8%) | |
| Moderate | 4 (1.6%) | 1 (0.4%) | |
| Not present | 227 (92%) | 218 (94%) | |
| Severe | 0 (0%) | 1 (0.4%) | |
| Tachycradia | 0.7 | ||
| Mild | 34 (14%) | 26 (11%) | |
| Moderate | 19 (7.6%) | 15 (6.3%) | |
| Not present | 196 (78%) | 197 (82%) | |
| Severe | 2 (0.8%) | 1 (0.4%) | |
| Heart attack | |||
| Not present | 244 (100%) | 231 (100%) | |
| Angioedema | |||
| Not present | 244 (100%) | 230 (100%) | |
| Bronchospasm | 0.5 | ||
| Mild | 0 (0%) | 1 (0.4%) | |
| Not present | 241 (100%) | 227 (100%) | |
| Fever | 0.3 | ||
| Mild | 50 (20%) | 34 (14%) | |
| Moderate | 26 (10%) | 19 (8.1%) | |
| Not present | 170 (67%) | 177 (75%) | |
| Severe | 7 (2.8%) | 6 (2.5%) | |
| Shortness of breath | 0.6 | ||
| Mild | 4 (1.6%) | 5 (2.2%) | |
| Moderate | 1 (0.4%) | 3 (1.3%) | |
| Not present | 238 (98%) | 222 (97%) | |
| 1 n (%) | |||
| 2 Fisher’s exact test; NA | |||
| Symptom | Pre-infusion N = 2641 |
Post-infusion N = 2601 |
p-value2 |
|---|---|---|---|
| Dizziness | 0.5 | ||
| Mild | 3 (1.2%) | 5 (2.0%) | |
| Not present | 256 (99%) | 247 (98%) | |
| Dyspepsia | 0.8 | ||
| Mild | 3 (1.2%) | 2 (0.8%) | |
| Moderate | 3 (1.2%) | 1 (0.4%) | |
| Not present | 253 (98%) | 247 (99%) | |
| Tremor | 0.090 | ||
| Mild | 4 (1.5%) | 0 (0%) | |
| Moderate | 0 (0%) | 1 (0.4%) | |
| Not present | 255 (98%) | 249 (100%) | |
| Pruritis | 0.9 | ||
| Mild | 1 (0.4%) | 1 (0.4%) | |
| Moderate | 1 (0.4%) | 0 (0%) | |
| Not present | 253 (99%) | 235 (99%) | |
| Severe | 0 (0%) | 1 (0.4%) | |
| Eruption | >0.9 | ||
| Mild | 1 (0.4%) | 1 (0.4%) | |
| Moderate | 1 (0.4%) | 0 (0%) | |
| Not present | 252 (99%) | 235 (100%) | |
| Bleeding | >0.9 | ||
| Mild | 10 (3.9%) | 9 (3.8%) | |
| Moderate | 2 (0.8%) | 2 (0.8%) | |
| Not present | 241 (95%) | 224 (95%) | |
| Severe | 1 (0.4%) | 1 (0.4%) | |
| Anorexia | 0.7 | ||
| Life-threatening | 0 (0%) | 1 (0.4%) | |
| Mild | 23 (9.2%) | 18 (7.7%) | |
| Moderate | 5 (2.0%) | 3 (1.3%) | |
| Not present | 222 (89%) | 213 (91%) | |
| Diarrhoea | 0.7 | ||
| Life-threatening | 0 (0%) | 1 (0.4%) | |
| Mild | 24 (9.5%) | 17 (7.3%) | |
| Moderate | 13 (5.1%) | 10 (4.3%) | |
| Not present | 211 (83%) | 201 (87%) | |
| Severe | 5 (2.0%) | 3 (1.3%) | |
| Nausea | 0.7 | ||
| Mild | 22 (8.7%) | 24 (10%) | |
| Moderate | 8 (3.2%) | 4 (1.7%) | |
| Not present | 221 (87%) | 208 (88%) | |
| Severe | 2 (0.8%) | 1 (0.4%) | |
| Vomiting | 0.4 | ||
| Mild | 19 (7.6%) | 13 (5.5%) | |
| Moderate | 8 (3.2%) | 3 (1.3%) | |
| Not present | 221 (88%) | 218 (92%) | |
| Severe | 3 (1.2%) | 2 (0.8%) | |
| Constipation | >0.9 | ||
| Mild | 1 (0.4%) | 0 (0%) | |
| Not present | 248 (100%) | 232 (100%) | |
| Headache | 0.025 | ||
| Mild | 12 (4.9%) | 3 (1.3%) | |
| Moderate | 0 (0%) | 1 (0.4%) | |
| Not present | 235 (95%) | 228 (98%) | |
| Hypertension | 0.9 | ||
| Mild | 4 (1.6%) | 5 (2.2%) | |
| Moderate | 1 (0.4%) | 1 (0.4%) | |
| Not present | 243 (98%) | 226 (97%) | |
| Hypotension | 0.6 | ||
| Mild | 16 (6.4%) | 10 (4.3%) | |
| Moderate | 2 (0.8%) | 2 (0.9%) | |
| Not present | 231 (93%) | 222 (95%) | |
| Tachycradia | 0.6 | ||
| Mild | 36 (14%) | 25 (10%) | |
| Moderate | 18 (7.1%) | 17 (7.0%) | |
| Not present | 195 (77%) | 198 (81%) | |
| Severe | 4 (1.6%) | 4 (1.6%) | |
| Heart attack | 0.5 | ||
| Moderate | 0 (0%) | 1 (0.4%) | |
| Not present | 245 (100%) | 231 (100%) | |
| Angioedema | |||
| Not present | 247 (100%) | 232 (100%) | |
| Bronchospasm | 0.5 | ||
| Mild | 0 (0%) | 1 (0.4%) | |
| Not present | 245 (100%) | 229 (100%) | |
| Fever | 0.4 | ||
| Mild | 41 (16%) | 27 (11%) | |
| Moderate | 25 (9.8%) | 25 (11%) | |
| Not present | 180 (71%) | 179 (76%) | |
| Severe | 8 (3.1%) | 5 (2.1%) | |
| Shortness of breath | 0.5 | ||
| Mild | 5 (2.0%) | 3 (1.3%) | |
| Moderate | 1 (0.4%) | 3 (1.3%) | |
| Not present | 242 (98%) | 226 (97%) | |
| 1 n (%) | |||
| 2 Fisher’s exact test; NA | |||